Fresh off the back of closing a $33m financing round, Subtle Medical has received US Food and Drug Administration (FDA) clearance for its artificial intelligence (AI)-based software for improving computed tomography (CT) images.
SubtleHD(CT) is a software-as-a-medical-device (SaMD) designed to reduce noise and improve low contrast detectability across CT images. The software is specifically designed to integrate into existing radiology workflows across diverse scanner fleets, including older systems that continue to play an important role in patient care, Subtle stated.
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Subtle Medical CEO, Ohad Arazi, commented: “Healthcare organisations are looking for ways to improve imaging performance while maximising the value of the infrastructure they already have.
“With SubtleHD(CT), we’re extending our expertise in AI-powered image enhancement to CT and taking another step toward our vision of helping providers enhance image quality across the imaging enterprise.”
FDA clearance for Subtle’s CT imaging software follows the US company’s completion of a $33m Series C financing round on 2 June. The company plans to apply the proceeds towards advancing the development and market penetration of its lead products globally. Coinciding with the close, the California-based company announced the appointment of Ohad Arazi as its new CEO. Arazi previously held CEO and leadership roles at companies including Change Healthcare, Zebra Medical Vision, and Clarius Mobile Health.
Meanwhile, SubtleHD(CT)’s FDA clearance comes only a short while after the agency’s greenlight for SubtleHD(PET), Subtle’s AI-imaging software designed to improve image quality and accelerate PET imaging workflows, on 27 May.
The SaMDs are the latest inductees to Subtle’s vendor-neutral AI Imaging Hub. Other tools within the suite include SubtleALIGN, a software that automatically aligns brain MR scans to the ‘ideal’ anatomical position, and SubtleSYNTH for generating MR imaging contrasts from existing sequences.
AI is having a significant impact across healthcare, with the combined AI market across the sector valued at $11.9bn in 2024 and projected to reach a valuation of $57.4bn in 2029, according to a report by GlobalData.
AI’s penetration in healthcare is having an outsized influence in the medical imaging space, due in part to a projected shortfall in radiologists given AI tools’ ability to ease caseloads and expedite radiologic workflows. A report by the Association of American Medical Colleges (AAMC) forecasts that the radiologist shortfall in the US could reach almost 42,000 by 2036.
